Lurasidone is a well-known dopaminergic (D2) and serotonin. (5-HT2A) receptor antagonist and is disclosed in U.S. Pat. Nos. 5,780,632 and 5,532,372. Lurasidone is the INN of a psychotropic compound (3aR,4S,7R,7aS)-2-[((1R,2R)-2-{[4-(1,2-benzisothiazol-3-yl)-piperazin-1-yl]methyl}cyclohexyl)methyl]hexahydro-1H-4,7-methanisoindol-1,3-dione hydrochloride represented by Formula (1).

A free form of lurasidone and an acid addition salt thereof are known to have psychotropic activities and are effective as therapeutic agents, particularly for schizophrenia or senile dementia, etc. Senile dementia is broadly classified into Alzheimer's dementia and cerebrovascular dementia, and it can be said that the two make up about 80% of senile dementia.
U.S. Pat. No. 5,532,372 discloses (3aR,4S,7R,7aS)-2-[((1R,2R)-2-{[4-(1,2-benzisothiazol-3-yl)-piperazin-1-yl]methyl}cyclohexyl)methyl]hexahydro-1H-4,7-methanisoindol-1,3-dione or its pharmaceutically acceptable salts and process for preparing thereof.
U.S. Pat. No. 7,605,260 B2 discloses process for preparing (3aR,4S,7R,7aS)-2-[((1R,2R)-2-{[4-(1,2-benzisothiazol-3-yl)-piperazin-1-yl]methyl}cyclohexyl)methyl]hexahydro-1H-4,7-methanisoindol-1,3-dione hydrochloride of Formula (1) from free base of 3aR,4S,7R,7aS)-2-[((1R,2R)-2-{[4-(1,2-benz isothiazol-3-yl)-piperazin-1-yl]methyl}cyclohexyl)methyl]hexahydro-1H-4,7-methanisoindol-1,3-dione using 1.8 to 5% aqueous hydrochloric acid solution in acetone.
U.S. Patent Publication No. US 2009/0285805 discloses a solution-type preparation of lurasidone or acid addition salt thereof prepared by incorporating one or more substances selected from benzyl alcohol, N,N-dimethylacetamide, lactic acid, anhydrous ethanol and propylene glycol.
International (PCT) Publication WO 2011/093522 A1 discloses cycloalkane derivative having a steric configuration of (3aR,4S,7R,7aS)-2-[((1R,2R)-2-{[4-(1,2-benzisothiazol-3-yl)-piperazin-1-yl]methyl}cyclohexyl)methyl]hexahydro-1H-4,7-methanisoindol-1,3-dione or its pharmaceutically acceptable salts, which was not disclosed in U.S. Pat. No. 5,532,372.
International (PCT) Publications WO 2011/136383 A1 and WO 2011/136384 A1 discloses process for preparing Lurasidone and intermediates thereof.
International (PCT) Publications WO 2012/123858 A1 and WO 2012/063246 A1 discloses amorphous form of lurasidone hydrochloride and process for its preparation.
International (PCT) Publication WO 2012/107890 A2 discloses crystalline forms of lurasidone hydrochloride and processes for its preparation.
International (PCT) Publication WO 2012/131606 A1 (the WO '606 A1) and J. Mol. Catalysis. A: Chemical, Vol. 206(1-2) Pg. 95-103 (2003) discloses the process for the preparation of (1R,2R)-cyclohexane-1,2-diylbis(methylene)dimethanesulfonate of Formula (B).

The WO '606 A1 also discloses the process for the preparation of (3aR,7aR)-4′-(benzo[d]isothiazole-3-yl)octahydrospiro]isoindole-2,1′-piperazin]-1′-ium mesylate of Formula (G) by reacting (1R,2R)-cyclohexane-1,2-diylbis(methylene)dimethanesulfonate of Formula (B) and 3-(piperazin-1-yl)benzo[d]isothiazole of Formula (F) in presence of base and a solvent.

International (PCT) publication WO 2011/002103 A1, IP.com Journal, 11(4A), 5; 2011, U.S. Patent Appl. Pub. No. 2011/0263847 A1 and European Patent EP 464846 B1 discloses various processes for the preparation of (3aR,7aR)-4′-(benzo[d]isothiazole-3-yl)octahydrospiro]isoindole-2,1′-piperazin]-1′-ium mesylate of Formula (G), which are herein cited as the reference in their entirety.
IP.com Journal Vol. 11(4A) Pg 5 (2011) discloses crystalline form of (3aR,7aR)-4′-(benzo[d]isothiazole-3-yl)octahydrospiro]isoindole-2,1′-piperazin]-1′-ium mesylate of Formula (G) characterized by x-ray powder diffraction pattern having peaks at 7.6°, 9.1°, 16.2°, 16.9°, 18.9°, 19.2°, 20.2° and 25.0°±0.2 2θ.
IP.com Journal Vol. 11(4A) Pg 26 (2011) discloses crystalline form of lurasidone free base of Formula (H) characterized by x-ray powder diffraction pattern having peaks at 11.3°, 14.1°, 15.2°, 15.7°, 16.4°, 16.7°, 18.1°, 19.2°, 20.1° and 22.4°±0.2 2θ.
International (PCT) Publication WO 2012/016569 A1 discloses the process for the preparation of (3aS,4R,7S,7aR)-hexahydro-4,7-methano-1H-isoindole-1,3-(2H)-dione of Formula (E) by reducing bicyclo[2.2.1]hept-5-ene-2-oxo-3-exo-dicarboxlyic acid anhydride of Formula (C) followed by reaction with aqueous ammonia.

The prior art discloses the process for the preparation of lurasidone hydrochloride and its intermediates. However, there still remains a need for alternative process for the preparation of intermediates of lurasidone and their crystalline forms, thereby providing an improved process for the preparation of lurasidone hydrochloride of Formula (1).